Devices

Device Surveillance Continues During Shutdown: Gottlieb

During the current government shutdown, FDA says it is continuing to conduct device post-market surveillance. In a series of Twitter posts, FDA commissioner Scott Gottlieb sought to reassure constituents, saying that “while it’s not business as usual at the agency, we are continuing to prioritize our device safety work both before and after medical devices come to market. With respect to post-market efforts, the agency is currently monitoring all medical device adverse events it receives, looking for concerns and signals that need to be addressed. If we find issues, we can and will act to protect Americans from imminent threats to health.”

Gottlieb also said FDA continues to process, review and classify all high-risk (Class I) and moderate-risk (Class II) medical device recalls. “We are then ensuring that the necessary steps are taken for those that pose an imminent threat to human life,” his posts say. “We are also continuing to conduct for-cause inspections of devices facilities when the agency believes an imminent threat to life or health exists, and working to bring back online surveillance inspections of high-risk devices as we have already announced for foods.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome